A single-center, single-arm clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19)

• Register: ChiCTR
• Last refreshed on: 2 March 2020
• Main ID: ChiCTR2000030424
• Date of registration: 2020-03-01
• Prospective Registration: Yes
• Primary sponsor: Henan Provincial People's Hospital
• Public title: A single-center, single-arm clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19)
• Scientific title: A single-center, single-arm clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19)
• Date of first enrolment: 2020-03-02
• Target sample size: Case series:30;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=50174
• Study type: Interventional study
• Study design: Single arm
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Wan Yuanhao
• Affiliation: He'nan Sincere Biotechnology Co., Ltd

• Name: Shao Fengmin
• Affiliation: He'nan Provincial People's Hospital

Key inclusion & exclusion criteria

Inclusion criteria: (1) aged >=18 years;
(2) positive COVID-19 nucleic acid was detected by RT-PCR in sputum/nasal swab/pharyngeal swab/lower respiratory tract secretions, or viral gene sequencing was detected in sputum/nasal swab/pharyngeal swab/lower respiratory tract secretions, which was highly homologous with known COVID-19;
(3) Confirmed to be diagnosed as COVID-19, meeting the diagnostic criteria for moderate and severe patients in the diagnosisin line with the release of a new coronavirus infection by the National Health and Medical Commission Diagnostic criteria for confirmed cases in the pneumonia diagnosis and treatment plan (trial version 6), and not significantly improved after treatment with the triple antiviral program;
(4) Informed consent has been signed.
Exclusion criteria: (1) known or suspected allergies to the components of azivudine tablets;
(2) women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
(3) participating in other clinical trials or taking experimental drugs within 12 weeks prior to administration
(4) severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);
(5) patients with severe renal insufficiency or receiving continuous renal replacement therapy or peritoneal dialysis
(6) Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

Age minimum: 18
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Novel Coronavirus Pneumonia (COVID-19)

Intervention(s)

Case series:Azvudine Tablet: D1: 10 mg/day,QD; Starting from D2: 5 mg/day,QD. Symptomatic treatment:Subjects were treated corresponding treament plan in line with the release of a new coronavirus infection by the National Health and Medical Commission Diagnostic criteria for confirmed cases in the pneumonia diagnosis and treatment;

Primary Outcome(s)

Sputum/nasal swab/pharyngeal swab/lower respiratory tract secretions were used to detect the negative conversion rate of the new coronavirus nucleic acid (tested daily after two days starting the azvudine tablets) and the negative conversion time.;

Secondary Outcome(s)

TTCR, Time to Clinical Recovery;Pulmonary CT/DR improvement rate;The frequency of respiratory aggravation;Time and proportion of temperature return to normal;time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.);time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms;rate of modorate type to severe type, rate of severe type to critical type;Time and proportion of improvement in CD4 and CD8 counts;

Source(s) of Monetary Support

Henan Sincere Biotechnology Co., Ltd

Ethics review

Status: Approved
Approval date: 26/08/2013
Contact:

[e-mail]

Qin Yan

[phone]

[e-mail]